Recall Z-0102-2023— ARROW INTERNATIONAL Inc.

Name: FDA recall Z-0102-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-14

Class II · Terminated

Class II FDA medical device recall by ARROW INTERNATIONAL Inc., initiated 2022-09-14, terminated 2024-01-19. It names one FDA 510(k) clearance: K161313. Product: ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.. Reason: Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1)..

Recalling firm: ARROW INTERNATIONAL Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-09-14
Terminated: 2024-01-19
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K161313 — ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic TechnologyArrow International, Inc. (Subsidiary of Teleflex, Inc.)·cleared 2016-08-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.

Reason for recall

Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).

Data sourced from openFDA. This site is unofficial and independent of the FDA.